Description of Collaborative Activity: |
To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, NCI convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019. This timely meeting brought together scientists and FDA regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection. Workshop Goals Assess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeutics; Discuss the knowledge gaps and future opportunities in the field; Provide feedback to National Cancer Institute (NCI) and National Institutes of Health (NIH) regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseases Workshop Focus Areas Standardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial design; Microbiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacy; Confounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factors; Clinical efficacy and safety of FMT and microbiome-based cancer therapy; Clinically relevant models and human translational studies; Data sharing; FDA regulatory issues;NCI Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Working Group;Since 2019 NCI FMT workshop, the Working Group continues hosting seminar series,;yearly to highlight the research discovery and assess the research needs. The most recent webinar is on Nov 6, 2022 in which Drs. Hassane Zarour and Giorgio Trinchieri, the world experts on FMT and cancer immunotherapy, discussed NCI funded study published in Science this year “Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients”. The next coming FMT talk will be on April 8th, 2022, at 2pmIn addition to the webinar, in FY 2022,;Working Group;is working on developing FOA: RFA:;Fecal Microbiota Transplants and Defined Microbiota Cancer Therapeutics Clinical Research Network.;Plan to present in DCTD meeting in April, May or July.Plan future meeting in 2024. NCI workshop on the “State of the Science: Cancer Complementary and Alternative Medicine Therapeutics Research” and the recent upsurge in the field of gut microbiota research suggest that the microbiome plays a role in cancer therapeutic outcomes. This may be especially important for patients receiving anti-PD-1 immunotherapy. To explore the potential role that fecal microbiota transplants (FMT) and pre/probiotics may play in cancer therapeutics and to address reproducibility and safety to inform translational human studies and clinical trials, NCI convened a “Strategic Workshop on Rigor and Reproducibility: Precision Fecal Microbiota Transplant and Microbiome Cancer Therapeutics” on September 5, 2019 (agenda). This timely meeting brought together scientists and FDA regulatory staff in the fields of FMT, pre/probiotics, nutrition, microbiome, synthetic biology, biomarkers, computation, immunology, gastroenterology, oncology, and infection.Workshop GoalsAssess the current state of clinical research and clinical trials involving FMT and microbiome-based cancer therapeuticsDiscuss the knowledge gaps and future opportunities in the fieldProvide feedback to NCI and NIH regarding future priority areas to enhance precision- and mechanism-based rigor and reproducibility of defined microbiome-based therapeutic clinical research for cancer and other diseasesWorkshop Focus AreasStandardization (material manufacture and quality control), FMT donor selection, microbiome measurement, clinical protocols, procedures, and trial designMicrobiome composition and function as biomarkers associated with cancer therapy, such as reproducibility, safety, and efficacyConfounding variables — host genetic and disease state, environment, antibiotics, diet and other lifestyle factorsClinical efficacy and safety of FMT and microbiome-based cancer therapyClinically relevant models and human translational studiesData sharingFDA regulatory issues |
